Method and device for performing orientation dependent oscillating positive expiratory pressure therapy

ABSTRACT

A respiratory device comprising a housing enclosing a chamber and an orientation indicator moveable with respect to the housing between a first position indicative of an orientation of the housing predetermined to be suitable for operation of the respiratory device, and a second position indicative of an orientation of the respiratory device predetermined to be less suitable for operation of the respiratory device. The orientation indicator is positioned in a location on the respiratory device visible to a user during the operation of the respiratory device.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/154,103, filed on Jun. 6, 2011, pending, which is acontinuation-in-part of U.S. application Ser. No. 12/711,032, filed onFeb. 23, 2010, now U.S. Pat. No. 8,485,179, which claims the benefit ofU.S. Provisional Application No. 61/154,661, filed on Feb. 23, 2009, andU.S. Provisional Application No. 61/181,200, filed on May 26, 2009, allof which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a respiratory treatment device, and inparticular, to an orientation dependent oscillating positive expiratorypressure (“OPEP”) device.

BACKGROUND

Each day, humans may produce upwards of 30 milliliters of sputum, whichis a type of bronchial secretion. Normally, an effective cough issufficient to loosen secretions and clear them from the body's airways.However, for individuals suffering from more significant bronchialobstructions, such as collapsed airways, a single cough may beinsufficient to clear the obstructions.

OPEP therapy represents an effective bronchial hygiene technique for theremoval of bronchial secretions in the human body and is an importantaspect in the treatment and continuing care of patients with bronchialobstructions, such as those suffering from chronic obstructive lungdisease. It is believed that OPEP therapy, or the oscillation ofexhalation pressure at the mouth during exhalation, effectivelytransmits an oscillating back pressure to the lungs, thereby splittingopen obstructed airways and loosening the secretions contributing tobronchial obstructions.

OPEP therapy is an attractive form of treatment because it can be easilytaught to most hospitalized patients, and such patients can assumeresponsibility for the administration of OPEP therapy throughout theirhospitalization and also once they have returned home. To that end, anumber of portable OPEP devices have been developed.

BRIEF SUMMARY

In one aspect, a respiratory device includes a housing enclosing achamber and an orientation indicator moveable with respect to thehousing between a first position indicative of an orientation of thehousing predetermined to be suitable for the operation of therespiratory device, and a second position indicative of an orientationof the housing predetermined to be less suitable for operation of therespiratory device. The orientation indicator may be positioned in alocation on the respiratory device visible to a user during theoperation of the respiratory device.

In another aspect, the respiratory device may be an OPEP device.Alternatively, the respiratory device may be a nebulizer.

In another aspect, an OPEP device includes a housing enclosing achamber, a chamber inlet, a chamber outlet, and a channel positioned inan exhalation flow path between the chamber inlet and the chamberoutlet. An air flow regulator is moveable with respect to the channel.Furthermore, an orientation indicator is moveable with respect to thehousing between a first position indicative of an orientation of thehousing predetermined to be suitable for administration of OPEP therapyto a user, and a second position indicative of an orientation of thehousing predetermined to be less suitable for administration of OPEPtherapy to the user. The orientation indicator may be positioned in alocation on the OPEP device visible to the user during theadministration of OPEP therapy.

In another aspect, the orientation indicator moves in response to achange in the orientation of the housing. A weight of the orientationindicator may bias the orientation indicator in the direction ofgravity. As such, the orientation indicator may be moveable in at leastone direction.

In another aspect, the respiratory device or the OPEP device may includea capsule enclosing the orientation indicator. The capsule may includean indicia for identifying a portion of the capsule in which thepresence of the orientation indicator indicates an orientation of thehousing predetermined to be suitable for the operation of therespiratory device, or for the administration of OPEP therapy. Thecapsule may be shaped so that the orientation indicator moves to thefirst position in response to a change in the orientation of the housingto an orientation predetermined to be suitable for operation of therespiratory device, or for the administration of OPEP therapy.

In yet another aspect, the orientation indicator may be a sphere. Theorientation indicator may also be a fluid. Alternatively, theorientation indicator may be in the form of a meter needle.

In another aspect, the chamber inlet may be configured to receiveexhaled air into the chamber, while the chamber outlet may be configuredto permit exhaled air to exit the chamber.

In a further aspect, a respiratory device includes a housing enclosing achamber and an orientation indicator configured to provide visual orauditory feedback to a user indicative of the suitability of theorientation of housing predetermined to be suitable for theadministration of the respiratory therapy.

In another aspect, the orientation indicator includes a microelectro-mechanical system gyroscope configured to sense the orientationof the housing. The orientation indicator may also include at least onelight for indicating the suitability of the orientation of the housingfor the administration of OPEP therapy. The orientation may also includean audio signaling device for indicating the suitability of theorientation of the housing for the administration of OPEP therapy.

In yet another aspect, a method of administering orientation dependentOPEP therapy includes passing a flow of exhaled air along an exhalationflow path defined between an inlet and an outlet of a chamber in an OPEPdevice, maintaining an air flow regulator in a channel positioned in theexhalation flow path for restricting the flow of exhaled air through thechannel, and moving the air flow regulator in repose to the flow ofexhaled air repeatedly between a first position where the flow ofexhaled air is restricted and a second position where the flow ofexhaled air is less restricted. The method also involves the step oforienting the OPEP device based on feedback provided by an orientationindicator on the OPEP device. The orientation indicator may provideeither visual feedback or auditory feedback to indicate the suitabilityof the orientation of the OPEP device for the administration of OPEPtherapy.

In a further aspect, a method of administering nebulizer therapyincludes providing a liquid stored in a reservoir, providing a source ofpressurized gas, and aerosolizing the liquid with the pressurized gas.The method further includes orienting the nebulizer based on feedbackprovided by an orientation indicator provided on the nebulizer. Theorientation indicator may provide either visual feedback or auditoryfeedback to indicate the suitability of the orientation of the reservoirfor the administration of nebulizer therapy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an OPEP device;

FIG. 2 is a cross-sectional view of the OPEP device of FIG. 1;

FIG. 3 is a cross-sectional view of a channel assembly of the OPEPdevice of FIG. 1;

FIG. 4 is a perspective view of an adjustment band of the OPEP device ofFIG. 1;

FIGS. 5A-C are cross-sectional views of the OPEP device of FIG. 1,illustrating movement of the adjustment band of FIG. 4 relative to thechannel assembly of FIG. 3;

FIG. 6 is a perspective view of the OPEP device of FIG. 1 configuredwith a nebulizer port for the simultaneous administration of OPEP andaerosol therapies;

FIG. 7 is a side view of an orientation indicator positioned on aportion of the OPEP device of FIG. 1;

FIGS. 8A-C are side views of the orientation indicator of FIG. 7,illustrating the visual feedback of the orientation indicator forvarious orientations of the OPEP device of FIG. 1;

FIGS. 9A-B are side views of an alternative embodiment of an orientationindicator in the form of a liquid or gas enclosed within a capsule;

FIG. 10 is a side view of an alternative embodiment of an orientationindicator in the form of a meter needle rotatably mounted to a housing;

FIGS. 11A-B are side views of the orientation indicator and the housingof FIG. 10 enclosed by a cover to provide an indicia of orientations ofthe device associated with the orientation indicator that are suitableand/or ideal for the device's operation;

FIGS. 12A-C are representative views of an alternative embodiment of anorientation indicator in the form of an electrical visual and/orauditory system;

FIG. 13 is a perspective view of a first commercially available OPEPdevice shown with orientation indicator of FIG. 7;

FIG. 14 is a perspective view of the first commercially available OPEPdevice shown with the orientation indicator of FIGS. 12A-12C;

FIG. 15 is a perspective view of a second commercially available OPEPdevice shown with the orientation indicator of FIG. 7;

FIG. 16 is a perspective view of the second commercially available OPEPdevice shown with the orientation indicator of FIGS. 12A-12C;

FIG. 17 is a perspective view of a commercially available nebulizershown with the orientation indicator of FIG. 7; and,

FIG. 18 is a perspective view of the same commercially availablenebulizer shown with the orientation indicator of FIGS. 12A-12C.

DETAILED DESCRIPTION

OPEP therapy is very effective within a range of operating conditions.For example, an adult human may have an exhalation flow rate rangingfrom 10 to 60 liters per minute, and may maintain a static exhalationpressure in the range of 10 to 20 cm H₂O. Within these parameters, OPEPtherapy is believed to be most effective when changes in the exhalationpressure range from 5 to 20 cm H₂O oscillating at a frequency of 10 to40 Hz. In contrast, an adolescent may have a much lower exhalation flowrate, and may maintain a lower static exhalation pressure, therebyaltering the operating conditions most effective for OPEP therapy.Likewise, the ideal operating conditions for an athlete may differ fromthose of an adult. As described below, the disclosed OPEP device isconfigurable and provides feedback to the user so that ideal operatingconditions may be selected and maintained.

Referring first to FIGS. 1-2, an OPEP device 100 is shown. In general,the OPEP device 100 includes a housing 102 enclosing a chamber 114, achamber inlet 104, and a chamber outlet 106. The housing 102 may also beassociated with a mouthpiece 108. Although the mouthpiece 108 is shownas being fixedly attached to the housing 102, it is envisioned that themouthpiece 108 may be removable and replaceable with a mouthpiece 108 ofa different size or shape. Alternatively, other user interfaces, such asbreathing tubes or gas masks (not shown) may be associated with thehousing 102. Preferably, the housing 102 is openable so that the chamber114 and the parts contained within the housing 102 can be periodicallyaccessed, cleaned, replaced, or selectively adjusted. The housing 102may be constructed of any durable material, such as a polymer (e.g.,Acrylonitrile Butadiene Styrene).

As shown, the housing 102 is generally egg-shaped. However, a housing ofany shape could be used. Furthermore, the chamber inlet 104 and thechamber outlet 106 could be any shape or series of shapes, such as aplurality of circular passages or linear slots. Likewise, the chamberinlet 104 and the chamber outlet 106 may be located elsewhere on thehousing 102. More importantly, it should be appreciated that thecross-sectional area of the chamber inlet 104 is but one of the factorsinfluencing the ideal operating conditions described above.

Referring to FIG. 2, a cross-sectional view of the OPEP device 100 showsthe components housed in the OPEP device 100. Those components include achannel assembly 116, an adjustment band 163, and inner and outerbushings 162, 164, which may operate to seal the chamber 114 and permitthe channel assembly 116 to move relative to the housing 102. The OPEPdevice 100 also includes an air flow regulator 120 that rests in achannel 118 in the channel assembly 116. The air flow regulator 120 ismoveably positioned within the channel 118 such that it is free to moveabout within the confines of at least a portion of the channel 118.

An exhalation flow path, identified by dotted line 111, is definedbetween the chamber inlet 104 and the chamber outlet 106. The OPEPdevice 100 also includes an orientation indicator 158 to provide a userwith visual feedback of the orientations of the OPEP device 100 suitableand/or ideal for providing OPEP therapy, as explained in greater detailbelow. In addition, a transparent window 160 may be included with thehousing 102 to permit the user to view the components contained therein,such as those that may be selectively adjusted and/or replaced to obtainthe desired operating conditions.

As shown in FIG. 2, the spherical shape of the air flow regulator 120 isadapted to restrict the flow of air through the channel 118. However,other sizes or shapes, such as a conical air flow regulator, could besubstituted to achieve a different range of restriction. In general, theair flow regulators shown and described herein are spherical and have adiameter of five-eighths or eleven-sixteenths of an inch. Likewise, theweight of the air flow regulator 120 could be altered by changing thematerial of the air flow regulator 120. For instance, the air flowregulator 120 could be made from a plastic, aluminum, copper, brass, orsteel. In this way, the OPEP device 100 is highly configurable and canbe altered according to the prescribed OPEP therapy.

Referring to FIG. 3, a cross-sectional view of the channel assembly 116is shown. In addition to the channel 118, the channel assembly 116comprises a pair of cylindrical support surfaces 166 about which thechannel assembly 116 may be supported by the inner and outer bushings162, 164 and pivotably attached to the housing 102 (FIG. 2). In thisway, the cylindrical support surfaces 166 act as a gimbal, permittingthe channel assembly 116 to rotate relative the housing 102 about anaxis defined between the cylindrical support surfaces 166. Furthermore,one of the cylindrical support surfaces 166 forms a passage 168 defininga portion of the exhalation flow path 111, as shown in FIG. 2.

Those skilled in the art will appreciate that the shape of the channel118 could be altered to achieve a different range of restriction. Forexample, a portion of the channel 118 in FIG. 3 is shown as beingconical, or having the shape of a truncated cone; however, one or moreportions of the channel 118 could alternatively, or in combination, bespherical or cylindrical. In view of these variables, it should beappreciated that an important factor affecting the administration ofOPEP therapy is the extent to which the air flow regulator 120 restrictsthe flow of air through the channel 118. Finally, the channel assembly116 may include an annular surface 170 about which the adjustment band163 may be mounted.

Turning to FIG. 4, the adjustment band 163 of the OPEP device 100 isshown. In general, the adjustment band 163 is shaped and sized to fitaround the annular surface 170 (FIG. 3) of the channel assembly 116 suchthat the adjustment band 163 and the channel assembly 116 arefrictionally engaged with one another, but may be rotated relative toone another under minimal force applied by the user. The adjustment band163 also includes a secondary weight 172, a retaining member 174 to keepthe air flow regulator 120 within the channel 118, and a gauge 176 toshow the position of the channel assembly 116 relative to the adjustmentband 163. Notably, when the adjustment band 163 is mounted to thechannel assembly 116, the position of the secondary weight creates acenter of mass offset from the axis formed between the cylindricalsupport surfaces 166, about which the channel assembly 116 is rotatable.

In operation, the OPEP device 100 administers OPEP therapy to a userwhile he or she exhales into the chamber inlet 104 through themouthpiece 108. When the OPEP device 100 is positioned in an uprightorientation, as shown in FIG. 2, the air flow regulator 120 moves underthe force of gravity into a first position, or a resting position,within the channel 118. With the air flow regulator 120 in the firstposition, the flow of air through the channel 118 is restricted.Depending on the shape and size of the air flow regulator 120 and/or thechannel 118, the air flow regulator 120 may restrict some or all of theexhaled air flowing through the channel 118. As the user continues toexhale, the pressure within the chamber 114 increases. As the pressureincreases, the force acting on the portion of the air flow regulator 120restricting the flow of exhaled air through the channel 118 alsoincreases. The force acting on the air flow regulator 120 continues toincrease during exhalation until the force of gravity acting on the airflow regulator 120 is overcome, and the air flow regulator 120 movesfrom the first position to a second position in the channel 118.

In the second position, the air flow regulator 120 is lifted away fromthe resting position near the bottom of the channel 118. Depending onthe shape and size of the air flow regulator 120 and/or the channel 118,the air flow regulator 120 may roll, slide, or jump to the secondposition. With the air flow regulator 120 in the second position, theflow of air through the channel 118 is less restricted than the flow ofair through the channel 118 when the air flow regulator 120 is in thefirst position. As such, more air is permitted to traverse the channel118 and exit the chamber outlet 106. In this way, the weight of the airflow regulator 120 offers a resistance to the flow of exhaled airthrough the channel 118 during exhalation.

After the airflow regulator 120 moves to the second position, and theflow of air through the channel 118 increases, the pressure in thechamber 114 begins to drop. As the pressure decreases, the force actingon the portion of the air flow regulator 120 restricting the flow of airthrough the channel 118 also decreases. When this force drops below theforce of gravity acting on the air flow regulator 120, the air flowregulator 120 returns to the first position, thereby increasing therestriction on the flow of air through the channel 118, and causing thepressure in the chamber 114 to rise again. As a user continues toexhale, this process repeats itself, effectively generating anoscillating pressure in the chamber 114. This oscillating pressure is inturn transmitted back through the chamber inlet 104 and into therespiratory system of the user, providing him or her with OPEP therapy.

As previously explained, the weight of the air flow regulator 120 offersa resistance to the flow of air through the channel 118. While the airflow regulator 120 is in the first position, the force of gravity actingon the air flow regulator 120 is balanced by the force derived from theexhalation pressure in the chamber 114 and the normal force from thechannel 118 acting on the air flow regulator 120. Accordingly, if theorientation of the channel 118 were to change, the magnitude anddirection of the normal force from the channel 118 would change, aswould the direction of the force acting on the air flow regulator 120derived from the exhalation pressure in the chamber 114. The directionand magnitude of gravitational forces acting on the air flow regulator120, however, would remain unchanged. Put another way, a change in theorientation of the OPEP device 100 may increase or decrease the inclineof the channel 118 the air flow regulator 120 must traverse to arrive atthe second position. Thus, the orientation of the channel 118, alongwith the position of the air flow regulator 120 within the channel 118,could prevent the air flow regulator 120 from sufficiently restrictingthe flow of air through the channel 118, such that the administration ofOPEP therapy would not be suitable and/or ideal, or alternatively,altogether impossible.

One advantage of the OPEP device 100 is its ability to reduce the effectof the orientation of the OPEP device 100 on the effectiveadministration of OPEP therapy. More specifically, as the housing 102 isrotated about the axis defined between the cylindrical support surfaces166, gravity acting on the secondary weight 172 in the adjustment band163 causes the channel assembly 116, and thus the channel 118, to rotaterelative to the housing 102 to a position where the secondary weight 172is below the axis between the cylindrical support surfaces 166. To aidin the creation of a seal, yet maintain mobility of the channel assembly116, the support surfaces 166 and the inner and outer bushings 162, 164may be made of suitable low friction materials (e.g., acetyl, nylon,etc.). Alternatively, a lubricant could be applied to the supportingsurfaces 166 and the inner and outer bushings 162, 164. In this way, theorientation of the channel assembly 116 does not substantially change asthe orientation of the housing 102 is rotated about the axis definedbetween the cylindrical support surfaces 166. To the extent theorientation of the housing 102 is rotated about the axis perpendicularto the axis defined between the cylindrical support surfaces 166, theorientation indicator 158 provides the user with visual feedback ofsuitable and/or ideal orientations for the administration of OPEPtherapy, as explained below.

The OPEP device 100 is also selectively adjustable to obtain the desiredoperating conditions of the OPEP therapy. As previously explained, theoscillation frequency and the amplitude of the OPEP therapy is dependentupon, amongst other variables, the angle of the channel 118 thatcontacts the air flow regulator 120, the normal force supplied by thechannel 118 against the air flow regulator 120, and the direction ofgravity relative thereto.

As shown in FIG. 2, the adjustment band 163 and the channel assembly 116may be frictionally engaged with one another about the annular surface170 of the channel assembly 116 such that both the channel assembly 116and the adjustment band 163 are supported by the inner and outerbushings 162, 164 and pivotably attached to the housing 102. Referringto FIGS. 5A-C, an illustration is provided showing the selectiverotation of the adjustment band 163 relative to the channel assembly116. A user may accomplish such an adjustment by opening the housing 102to access the components contained therein, or by any other suitablemeans.

In FIG. 5A, the channel assembly 116 is shown in one possibleorientation relative to the adjustment band 163. Notably, the secondaryweight 172 is located below the axis defined between the supportsurfaces 166 (see FIG. 2), as the force of gravity biases the adjustmentband 163 and secondary weight 172 to this location. To adjust thefrequency and amplitude of the OPEP therapy provided by the OPEP device100, a user may overcome the frictional engagement between theadjustment band 163 and the channel assembly 116 to rotate theadjustment band 163 relative to the channel assembly 116, as shown inFIG. 5B. Then, as shown in FIG. 5C, once the adjustment band 163 isreleased and the frictional engagement re-established, the adjustmentband 163, and thus the channel assembly 116, will rotate under the forceof gravity back to a position where the secondary weight 172 is locatedunder the axis defined between the cylindrical support surfaces 166. Byadjusting the orientation of the channel assembly 116 relative to theadjustment band 163 shown in FIG. 5A to the orientation shown in FIG.39C, the angle of the channel 118 that contacts the air flow regulator120, the normal force supplied by the channel 118, and the direction ofgravity relative thereto will also have changed. As shown in FIG. 2,such orientations may be viewed by the user through the transparentwindow 160 included with the housing 102. Furthermore, predeterminedorientations may be selected by the user according to the gauge 176located on the adjustment band 163.

Referring now to FIG. 6, the OPEP device 100 may also be adapted toprovide simultaneous administration of OPEP and nebulizer therapies. Asshown, the OPEP device 100 may include a nebulizer port 110 connectableto any number of commercially available nebulizers, such as theAEROECLIPSE® II breath-actuated nebulizer available from Trudell MedicalInternational of London, Canada. Descriptions of suitable nebulizers maybe found in U.S. Pat. Nos. 4,150,071; 5,287,847; 5,584,285; 5,823,179;6,085,741, the entireties of which are herein incorporated by reference.

The nebulizer port 110 may also include a one-way valve (not shown)configured to open on inhalation and close on exhalation. In thisconfiguration, an inhalation flow path is formed between the nebulizerport 110 and the chamber inlet 104 via the chamber 114. If the OPEPdevice 100 is connected to a nebulizer, an aerosol medicament may bedrawn from the nebulizer into the respiratory system of the user uponinhalation. If the OPEP device 100 is not connected to a nebulizer, theuser may inhale through the nebulizer port 110 the air surrounding theOPEP device 100, or air from a stand-alone air supply connected to thenebulizer port 110. However, in both cases, exhaled air is forced totraverse the channel 118 and exit the OPEP device 100 through thechamber outlet 106. Alternatively, the OPEP device 100 may include aseparate inhalation valve (not shown) or omit the nebulizer port 110altogether, in which case the user would have to inhale through a sourceexternal to the OPEP device 100, such as through his or her nose.Notably, the inhalation flow path from the nebulizer port 110 to themouthpiece 108 bypasses the channel 118, thereby reducing the potentialfor loss of expensive medicament.

As illustrated in FIGS. 1-2 and described above, the OPEP device 100 mayinclude an orientation indicator 158 to provide a user with visualfeedback of the suitable and/or ideal orientation of the OPEP device 100for the administration of OPEP therapy. By way of example, FIG. 7 showsa portion of the OPEP device 100 with an orientation indicator 158positioned on the housing 102 in a location relative to the mouthpiece108 such that, as the user exhales into the mouthpiece 108, the user isable to view the orientation indicator 158 to determine whether theorientation of the OPEP device 100 is suitable and/or ideal for theadministration of OPEP therapy. In this regard, a user is able to adjustthe orientation of the OPEP device 100 in response to the visualfeedback received from the orientation indicator 158 during theadministration of OPEP therapy.

As shown in FIGS. 2 and 7, the orientation indicator 158 is enclosed bya capsule 178. The indicator 158 may be comprised of any suitablematerial, such as a plastic, and may be spherically shaped. The capsule178 may be shaped like a pair of cones whose bases are coplanar, suchthat the angles of the conic sections define the range of orientationssuitable and/or ideal for the administration of OPEP therapy (e.g.,+/−10°). However, the capsule 178 could comprise any number of othershapes depending on the range of desired orientations.

The capsule 178 may be connected to the OPEP device 100 such thatmovement of the OPEP device 100 within the predetermined range oforientations causes the indicator 158 to remain in a portion of thecapsule 178 near the coplanar bases, thus indicating a suitable and/orideal orientation of the OPEP device 100 for the administration of OPEPtherapy. Likewise, the capsule 178 may be shaped and connected to theOPEP device 100 such that movement of the OPEP device 100 within aseparate predetermined range of orientations causes the indicator 158 tomove to a portion of the capsule 178 near either tip of one of the pairof cones, thereby indicating an orientation of the OPEP device 100 notsuitable or ideal for the administration of OPEP therapy. As a furtheraid to the user, the capsule 178 may include an indicia identifying theportion of the capsule 178 in which the presence of the indicator 158indicates an orientation of the OPEP device 100 suitable and/or idealfor the administration of OPEP therapy. In FIG. 7, for example, theindicia is a non-transparent material or coating 179 surrounding thecapsule 178.

An illustration of the visual feedback provided by the orientationindicator 158 is shown in FIGS. 8A-C. As seen in FIGS. 8A and 8C, whenthe OPEP device 100 is rotated about the axis perpendicular to thecylindrical support surfaces 166 described above to an orientation notsuitable for or ideal to the administration of OPEP therapy, theorientation indicator 158 moves away from the center of the capsule 178and behind the non-transparent material 179 surrounding the capsule 178.In contrast, while the OPEP device 100 is maintained in an orientationsuitable and/or ideal for the administration of OPEP therapy, theindicator 158 remains in the center portion of the capsule 178, as shownin FIG. 8B. In this way, the orientation indicator 158 provides the userwith visual feedback of orientations of the OPEP device 100 suitableand/or ideal for the administration of OPEP therapy and permits him orher to change the orientation of the OPEP device 100 in responsethereto.

Alternatively, as shown in FIGS. 9A-9B, an orientation indicator 190 maycomprise a fluid, such as a gas or low-density liquid, which is enclosedby a capsule 192 filled with a higher-density fluid 194. Thus, theorientation indicator 190 may appear to the user as a bubble or massenclosed within the capsule 192. As with the previously describedexample, and depending on the geometry of the capsule 192, theorientation indicator 190 may float to portions of the capsule 192 inresponse to a change in orientation of the capsule 192 and associateddevice. Likewise, an indicia 196 may be provided on the capsule 192identifying the portion of the capsule in which the presence of theorientation indicator 190 indicates an orientation of the associateddevice suitable and/or ideal for operation, for example, theadministration of OPEP therapy.

Turning to FIGS. 10-11B, an alternative embodiment of an orientationindicator 180 is shown. In FIG. 10, the orientation indicator 180 takesthe form of a meter needle pivotably attached to a housing 182 about apin 184. As with the previously described embodiment, the housing 182may be positioned on an OPEP device or other respiratory device in alocation such that the user may view the orientation indicator duringoperation of the device. The orientation indicator 180 further comprisesa counterweight 186 disposed at one end of the meter needle such that,as the orientation of the associated device is changed, the orientationindicator rotates about pin 184 under the force of gravity to maintainalignment with the direction of gravity.

As shown in FIGS. 11A and 11B, a cover 188 removably attached to thehousing 182 encloses the orientation indicator 180 and provides the userwith an indicia of the range of orientations of the associated devicesuitable and/or ideal for its operation. For example, as shown in FIGS.11A and 11B, respectively representing upright and rotated positions ofthe associated device, so long as the appropriate end of the orientationindicator is visible to a user (i.e., not the counterweight 186), thedevice is in an orientation suitable and/or ideal for the administrationof OPEP therapy. Alternative predetermined ranges of orientations may beselected by changing the shape of the cover to show or hide a largerportion of the housing 182.

Referring now to FIGS. 12A-C, representative views of an alternativeembodiment of an orientation indicator 200 are shown. FIG. 12A is aperspective view of the orientation indicator 200 contained withinhousing 202; FIG. 12B is a block diagram showing the operatingcomponents of the orientation indicator 200; and, FIG. 12C is a top viewof the orientation indicator 200 without the housing 202.

In general, the operating components of the orientation indicator 200comprise a micro electro-mechanical gyroscope 204, a power source 206,one or more visual or auditory indicators 208, 210, and a circuit 212for connecting all of the same and analyzing the output of the gyroscope204. These operating components are mounted on a circuit board 214.

Those skilled in the art will appreciate that the microelectro-mechanical gyroscope 204 may be selected from any number ofcommercially available products, and the power source 206 may beselected from any number of commercially available batteries. Likewise,the one or more visual indicators may be selected from any number oflighting products, such as, for example, one or more different coloredlight emitting diodes. Similarly, the one or more auditory indicatorsmay by selected from any number of audio signaling devices, includingbuzzers, beepers, bells, alarms, speakers, or the like.

In operation, the orientation indicator 200 may be connected to thehousing 102 of the OPEP device 100 and configured in any number of waysfor indicating an orientation of the housing 102 of the OPEP device 100predetermined to be suitable and/or ideal for administration of OPEPtherapy to a user. For example, the one or more visual indicators mayinclude a green light configured to illuminate when the housing 102 ofthe OPEP device 100 is in a position predetermined to be suitable foradministration of OPEP therapy. Or, the one or more visual indicatorsmay also include a red light configured to illuminate when the housing102 of the OPEP device 100 is in a position predetermined to be lesssuitable for the administration of OPEP therapy. Alternatively, theillumination of a single light may indicate a suitable or less suitableposition of the housing 102. Similarly, the orientation indicator 200may provide one or more auditory indicators, such as a beep or a warningtone, indicative of a suitable or a less suitable position of thehousing 102. Likewise, any combination or variation of the aboveexamples may be used to indicate the suitability of a particularorientation of the housing.

As previously explained, the suitable and/or ideal operation of the OPEPdevice 100 may be maintained when the OPEP device 100 is rotated aboutthe axis defined between the cylindrical support surfaces 166. However,when the OPEP device 100 is rotated perpendicular to the axis definedbetween the cylindrical support surfaces 166, the desired and/or idealoperating conditions are impacted, such that visual or auditory feedbackfrom an orientation indicator becomes relevant. Likewise, for anyrespiratory device that may benefit from the device's orientation forsuitable and/or ideal operation, it is envisioned that the orientationindicators described above would provide users with visual or auditoryfeedback indicative of suitable and/or ideal orientations for a device'soperation. Examples of other respiratory devices on which theorientation indicators described above may be mounted includenebulizers, pressurized metered dose inhalers, aerosol holding chambers,peak flow meters and so on.

For example, the orientation indicators described above may be utilizedon other commercially available OPEP devices. FIGS. 13-14 show thedisclosed orientation indicators mounted on an embodiment of an OPEPdevice 300 shown and described in U.S. Pat. Nos. 6,776,159 and7,059,324, the entireties of which are herein incorporated by reference,and commercially available under the trade name ACAPELLA® from SmithsMedical of St. Paul, Minn. Likewise, FIGS. 15-16 show the disclosedorientation indicators mounted on an embodiment of an OPEP device 400shown and described in U.S. Pat. No. 5,018,517, the entirety of which isherein incorporated by reference, and commercially available under thetrade name FLUTTER® from Axcan Scandipharm Inc. of Birmingham, Ala.

In another example, the orientation indicators described above may beutilized on commercially available nebulizers. FIGS. 17-18 show thedisclosed orientation indicators mounted on an embodiment of a nebulizer500 shown and described in U.S. Pat. Nos. 7,568,480 and 7,905,228, theentireties of which are herein incorporated by reference, andcommercially available under the trade name AEROECLIPSE® II from TrudellMedical International of London, Canada. In general, nebulizers includea reservoir of a liquid medicament and a source of pressurized gas foraerosolizing the liquid. Typically, the reservoir is in fluidcommunication with the pressurized gas, for example, by means of achannel through which the liquid medicament may be drawn from thereservoir. However, in such embodiments, the orientation of thereservoir may be critical in preventing the liquid medicament fromleaking out of the reservoir, and in permitting the liquid medicament tobe entrained up the channel. In that regard, the typical nebulizer maybenefit from the visual or auditory feedback of the orientationindicators described above.

The foregoing description has been presented for purposes ofillustration and description, and is not intended to be exhaustive or tolimit the inventions to the precise forms disclosed. It will be apparentto those skilled in the art that the present inventions are susceptibleof many variations and modifications coming within the scope of thefollowing claims. For example, multiple orientation indicators may beutilized on devices whose suitable and/or ideal operation is impacted bymovement of the device about more than one axis of rotation.Alternatively, the geometry of a capsule enclosing an orientationindicator on such a device may be configured such that the orientationindicator is capable of moving in more than one direction, therebyproviding a more dynamic indication of the suitability of theorientation of the device

What is claimed is:
 1. An oscillating positive expiratory pressuredevice comprising: a housing; an inlet configured to permit air to enterthe housing; an outlet configured to permit air to exit the housing; aflow path defined between the inlet and the outlet; an air flowregulator configured to move between a closed position where a flow ofair along the flow path is restricted, and an open position where theflow of air along the flow path is less restricted than when the airflow regulator is in the closed position; and, an electronic sensorconfigured to transmit a signal external to the housing indicating asuitability of an orientation of the housing, relative to a direction ofgravity, for administration of oscillating positive expiratory pressuretherapy.
 2. The oscillating positive expiratory pressure device of claim1, wherein movement of the air flow regulator between the closedposition and the opening position is dependent on the orientation of thehousing relative to the direction of gravity.
 3. The oscillatingpositive expiratory pressure device of claim 1, wherein the electronicsensor comprises an electro-mechanical sensor.
 4. The oscillatingpositive expiratory pressure device of claim 1, wherein the electronicsensor comprises a gyroscope.
 5. The oscillating positive expiratorypressure device of claim 1, wherein the signal is configured to generatea visual output indicative of the orientation of the housing.
 6. Theoscillating positive expiratory pressure device of claim 5, wherein thevisual output is a light.
 7. The oscillating positive expiratorypressure device of claim 5, wherein the visual output comprises aplurality of color-coded indicators, wherein each color of the pluralityof color-coded indicators represents a degree of the suitability of theorientation of the housing.
 8. The oscillating positive expiratorypressure device of claim 1, wherein the signal is configured to generatean auditory output indicative of the orientation of the housing.
 9. Theoscillating positive expiratory pressure device of claim 1, wherein thesignal is configured to generate an alarm.
 10. An oscillating positiveexpiratory pressure device comprising: a housing; an inlet configured topermit air to enter the housing; an outlet configured to permit air toexit the housing; a flow path defined between the inlet and the outlet;an air flow regulator configured to move between a closed position wherea flow of air along the flow path is restricted, and an open positionwhere the flow of air along the flow path is less restricted than whenthe air flow regulator is in the closed position; and, anelectro-mechanical sensor configured to transmit an electronic signalexternal to the housing indicating a suitability of an orientation ofthe housing, relative to a direction of gravity, for administration ofoscillating positive expiratory pressure therapy.
 11. The oscillatingpositive expiratory pressure device of claim 10, wherein movement of theair flow regulator between the closed position and the opening positionis dependent on an orientation of the housing relative to the directionof gravity.
 12. The oscillating positive expiratory pressure device ofclaim 10, wherein the electro-mechanical sensor comprises a gyroscope.13. The oscillating positive expiratory pressure device of claim 10,wherein the electronic signal is configured to generate a visual outputindicative of the suitability of the orientation of the housing foradministration of oscillating positive expiratory pressure therapy. 14.The oscillating positive expiratory pressure device of claim 13, whereinthe visual output is a light.
 15. The oscillating positive expiratorypressure device of claim 13, wherein the visual output comprises aplurality of color-coded indicators, wherein each color of the pluralityof color-coded indicators represents a degree of the suitability of theorientation of the housing for administration of oscillating positiveexpiratory pressure therapy.
 16. The oscillating positive expiratorypressure device of claim 10, wherein the electronic signal is configuredto generate an auditory output indicative of the suitability of theorientation of the housing for administration of oscillating positiveexpiratory pressure therapy.
 17. The oscillating positive expiratorypressure device of claim 10, wherein the electronic signal is configuredto generate an alarm.
 18. The oscillating positive expiratory pressuredevice of claim 10, further comprising a battery for powering theelectro-mechanical sensor, and a circuit for analyzing the electronicsignal generated by the electro-mechanical sensor.
 19. An oscillatingpositive expiratory pressure device comprising: a housing; an inletconfigured to permit air to enter the housing; an outlet configured topermit air to exit the housing; a flow path defined between the inletand the outlet; an air flow regulator configured to move between aclosed position where a flow of air along the flow path is restricted,and an open position where the flow of air along the flow path is lessrestricted than when the air flow regulator is in the closed position;and, an electro-mechanical gyroscope configured to transmit a signalexternal to the housing for generating an indication of the suitabilityof an orientation of the housing, relative to a direction of gravity,for administration of oscillating positive expiratory pressure therapy;wherein movement of the air flow regulator between the closed positionand the opening position is dependent on an orientation of the housingrelative to the direction of gravity.
 20. The oscillating positiveexpiratory pressure device of claim 1, wherein the signal is indicativeof a degree of the suitability of the orientation of the housing. 21.The oscillating positive expiratory pressure device of claim 1, whereinthe sensor is configured to generate the signal independent of the flowof air along the flow path.